Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days [ Time Frame: 50% or more of the total nutritional support days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]

Number of times tubes replaced and number of subjects refusing replacement [ Designated as safety issue: No ]

Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level [ Time Frame: Not indicated ] [ Designated as safety issue: No ]

Days of enteral (tube feeding) and total parenteral nutrition [ Designated as safety issue: No ]

Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy [ Time Frame: week 12 or beginning course of Chemotherapy ] [ Designated as safety issue: No ]

Duration of hospitalization [ Designated as safety issue: No ]

Need for post-discharge nutritional support [ Designated as safety issue: No ]

Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)

Other Name: Non indicated

Dietary Supplement: therapeutic nutritional supplementation

enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.

Other Name: not indicated

Detailed Description:

OBJECTIVES:

Primary

To determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors.

Secondary

To determine the safety of proactive enteral nutrition in these patients.

To evaluate the effect of enteral nutrition on nutritional status in these patients.

OUTLINE: Patients have a small (6 or 8 French) nasogastral feeding tube or enterostomy tube inserted after diagnosis. Peptamen® AF tube feeding is administered via the enteral tube. Tube feedings are started as a continuous drip using an enteral feeding pump with a subsequent steady daily rate increase. Patients receive enteral feeding during courses 1-4 of chemotherapy.

Eligibility

Ages Eligible for Study:

1 Year to 21 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Newly confirmed diagnosis of 1 of the following:

Acute myeloid leukemia

Myelodysplastic syndromes

Sarcoma

Any other stage IV solid tumor including:

Wilms

Neuroblastoma

Hepatoblastoma

Any primary cancer of the central nervous system including:

Cerebellar astrocytoma

Medulloblastoma

Ependymoma

Spine tumors

Exclusion Criteria:

No contraindication to enteral tube feeding including, but not limited to, any of the following:

All clinically indicated medications are permitted during the course of the study

No other concurrent nutritional supplements

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624962